510(k) K915382

AMOENA AFFINITY MODEL #802 by Coloplast Corp. — Product Code KCZ

K915382 is an FDA 510(k) premarket notification submitted by Coloplast Corp. for the device "AMOENA AFFINITY MODEL #802". The FDA issued a decision of Substantially Equivalent on January 14, 1992. The device falls under product code KCZ (Prosthesis, Breast, External, Used With Adhesive), a Class I device regulated under 21 CFR 878.3800. Coloplast Corp. has at least 10 other 510(k) clearances on record.